IN2Pharma
Consultancy and outsourcing firm providing regulatory, quality assurance, pharmacovigilance, medical support and compliance services for pharmaceutical, medical device, cosmetic and food supplement companies, with a focus on clients in the Benelux region.
Industries
Nr. of Employees
small (1-50)
IN2Pharma
Services
Assume regulatory, quality assurance, pharmacovigilance and medical responsibilities for client organisations in the Benelux region, including representation to authorities where required.
Assistance with preparation and maintenance of marketing authorisation dossiers and interactions with national and regional competent authorities.
Pharmacovigilance, materiovigilance, cosmetovigilance and food supplement safety planning services, including adverse event reporting and compliance with reporting obligations.
Quality assurance support including GDP and GMP compliance, importation activities and batch release services.
Preparation and review of scientific and medical documents and the development and delivery of medical training courses.
Assessment and support to ensure promotional materials and sponsored activities comply with applicable regulations.
Assume regulatory, quality assurance, pharmacovigilance and medical responsibilities for client organisations in the Benelux region, including representation to authorities where required.
Assistance with preparation and maintenance of marketing authorisation dossiers and interactions with national and regional competent authorities.
Pharmacovigilance, materiovigilance, cosmetovigilance and food supplement safety planning services, including adverse event reporting and compliance with reporting obligations.
Quality assurance support including GDP and GMP compliance, importation activities and batch release services.
Preparation and review of scientific and medical documents and the development and delivery of medical training courses.
Assessment and support to ensure promotional materials and sponsored activities comply with applicable regulations.
Expertise Areas
- Regulatory affairs
- Pharmacovigilance and vigilance
- Quality assurance (GMP/GDP)
- Medical writing and training
Key Technologies
- Pharmacovigilance/adverse event reporting systems
- GMP compliance processes
- GDP compliance processes
- Regulatory submission workflows
News & Updates
Summary of additional guidance from a national body on the use of 'absolute' claims for food supplements and a vitamins/minerals table to avoid misleading claims.
Overview of recent updates to the Dutch Medicines Act covering the Medicines Evaluation Board composition and manufacturer licensing requirements.
Summary of recent changes to Good Pharmacovigilance Practices (GVP) guidance including new guidance on masking personal data in ICSRs.
Article describing suspension of a law provision related to medicine unavailability and implications for wholesalers and distribution.
Summary of additional guidance from a national body on the use of 'absolute' claims for food supplements and a vitamins/minerals table to avoid misleading claims.
Overview of recent updates to the Dutch Medicines Act covering the Medicines Evaluation Board composition and manufacturer licensing requirements.
Summary of recent changes to Good Pharmacovigilance Practices (GVP) guidance including new guidance on masking personal data in ICSRs.
Article describing suspension of a law provision related to medicine unavailability and implications for wholesalers and distribution.